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A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Lead sponsor
Asset
Albiglutide
Subcutaneous · GLP-1 agonist
Listed sites
358
Recruiting sites
—
Enrollment
685
actual
Study population
Type 2 diabetes
Key I/E criterion
•BMI 20-45
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange From Baseline in Body Weight at Week 52
Time frame:Baseline and Week 52
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), Kilograms | 95% CI |
|---|---|---|
| Placebo + Metformin + Glimepiride | -0.40 | — |
| Pioglitazone + Metformin + Glimepiride | 4.43 | — |
| Albiglutide + Metformin + Glimepiride | -0.42 | — |
Change From Baseline in Body Weight at Week 104 and Week 156
Time frame:Baseline, Week 104, and Week 156
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kilograms | 95% CI |
|---|---|---|
| Placebo + Metformin + GlimepirideWeek 104, n=12, 130, 104 | -2.16 | — |
| Week 156, n=9, 90, 71 | -4.47 | — |
| Pioglitazone + Metformin + GlimepirideWeek 104, n=12, 130, 104 | 6.28 | — |
| Week 156, n=9, 90, 71 | 6.52 | — |
| Albiglutide + Metformin + GlimepirideWeek 104, n=12, 130, 104 | -0.90 | — |
| Week 156, n=9, 90, 71 | -1.53 | — |
Glycemic / diabetes
7 endpointsChange From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
Time frame:Baseline and Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), Percentage of HbA1c in the blood | 95% CI |
|---|---|---|
| Placebo + Metformin + Glimepiride | 0.33 | — |
| Pioglitazone + Metformin + Glimepiride | -0.80 | — |
| Albiglutide + Metformin + Glimepiride | -0.55 | — |
Change From Baseline in HbA1c at Week 104 and Week 156
Time frame:Baseline, Week 104, and Week 156
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage of HbA1c in the blood | 95% CI |
|---|---|---|
| Placebo + Metformin + GlimepirideWeek 104, n=12, 130, 104 | -0.32 | — |
| Week 156, n=9, 89, 71 | -0.10 | — |
| Pioglitazone + Metformin + GlimepirideWeek 104, n=12, 130, 104 | -1.09 | — |
| Week 156, n=9, 89, 71 | -0.97 | — |
| Albiglutide + Metformin + GlimepirideWeek 104, n=12, 130, 104 | -0.76 | — |
| Week 156, n=9, 89, 71 | -0.46 | — |
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time frame:Baseline and Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (least_squares_mean), Millimoles per liter (mmol/L) | 95% CI |
|---|---|---|
| Placebo + Metformin + Glimepiride | 0.64 | — |
| Pioglitazone + Metformin + Glimepiride | -1.74 | — |
| Albiglutide + Metformin + Glimepiride | -0.69 | — |
Change From Baseline in FPG at Week 104 and Week 156
Time frame:Baseline, Week 104, and Week 156
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), Millimoles per liter (mmol/L) | 95% CI |
|---|---|---|
| Placebo + Metformin + GlimepirideWeek 104, n=12, 128, 103 | 0.43 | — |
| Week 156, n=9, 88, 71 | -0.50 | — |
| Pioglitazone + Metformin + GlimepirideWeek 104, n=12, 128, 103 | -1.98 | — |
| Week 156, n=9, 88, 71 | -1.94 | — |
| Albiglutide + Metformin + GlimepirideWeek 104, n=12, 128, 103 | -0.99 | — |
| Week 156, n=9, 88, 71 | -0.88 | — |
Time to Hyperglycemia Rescue
Time frame:From the start of study medication until the end of the treatment (up to Week 156)
time to event, event
Posted result
| Group | Value (median), Weeks | 95% CI |
|---|---|---|
| Placebo + Metformin + Glimepiride | 49.57 | 38.86 – 55.14 |
| Pioglitazone + Metformin + Glimepiride | NA | NA – NA |
| Albiglutide + Metformin + Glimepiride | 137.71 | 93.71 – NA |
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52
Time frame:Week 52
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Placebo + Metformin + GlimepirideHbA1c <6.5% | 4 | — |
| HbA1c <7.0% | 10 | — |
| HbA1c <7.5% | 19 | — |
| Pioglitazone + Metformin + GlimepirideHbA1c <6.5% | 37 | — |
| HbA1c <7.0% | 94 | — |
| HbA1c <7.5% | 150 | — |
| Albiglutide + Metformin + GlimepirideHbA1c <6.5% | 27 | — |
| HbA1c <7.0% | 79 | — |
| HbA1c <7.5% | 126 | — |
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156
Time frame:Week 156
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Placebo + Metformin + GlimepirideHbA1c <6.5% | 1 | — |
| HbA1c <7.0% | 3 | — |
| HbA1c <7.5% | 5 | — |
| Pioglitazone + Metformin + GlimepirideHbA1c <6.5% | 23 | — |
| HbA1c <7.0% | 44 | — |
| HbA1c <7.5% | 68 | — |
| Albiglutide + Metformin + GlimepirideHbA1c <6.5% | 16 | — |
| HbA1c <7.0% | 26 | — |
| HbA1c <7.5% | 45 | — |
Publications (3)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Diabetes research and clinical practice2017 Sep (month)PMID28683300doi:10.1016/j.diabres.2017.06.013via clinicaltrials gov reference derived + pubmed nct search
- Postgraduate medicine2014 Nov (month)PMID25387217doi:10.3810/pgm.2014.11.2836via clinicaltrials gov reference derived + pubmed nct search
- Postgraduate medicine2014 May (month)PMID24918790doi:10.3810/pgm.2014.05.2754via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.